Cleared Traditional

K983376 - THE APTUS (AUTOMATED) APPLICATON OF THE...

K983376 is an FDA 510(k) clearance for THE APTUS (AUTOMATED) APPLICATON OF THE..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K983376 · Zeus Scientific, Inc. · Immunology device

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Nov 1998

Decision

54d

Days

Class 2

Risk

K983376 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZY.... Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K983376

510(k) Number	K983376 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 25, 1998
Decision Date	November 18, 1998
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

50d faster than avg

Panel avg: 104d · This submission: 54d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code	LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.5100

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LLL Extractable Antinuclear Antibody, Antigen And Control

All 127

Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K983376.

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THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

K983423 · Zeus Scientific, Inc. · Nov 1998

THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET

K983425 · Zeus Scientific, Inc. · Nov 1998

THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC

K983426 · Zeus Scientific, Inc. · Nov 1998

FDA 510(k) Resources - Immunology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.